Kornimate/medical-research-clean huggingface dataset:
varicella zoster vaccine in patients with plaque psoriasis treated with biologic therapy

Conditions: Psoriasis

Summary: this study will evaluate the ability of the vaccine to produce antibodies against herpes zoster virus (shingles) and safety of vaccination with varicella zoster vaccine in patients with moderate to severe psoriasis who will initiate biologic therapy 4 to 6 weeks after vaccination. varicella zoster vaccine will be administered 4 to 6 weeks prior to receipt of biological therapy and will be compared against placebo. this double-blind study will enroll approximately 50 adult patients with moderate-to-severe plaque psoriasis in approximately 3 centers in canada. study products will be assigned randomly at a 4:1 ratio. for each patient who is included, the study may last up to 22 weeks, including the screening and the follow-up period. during the study, subjects will come to the dermatology clinic up to 4 occasions: for a screening visit, baseline visit, day 42 as well as 84 days after they started taking the biological treatment for a last visit. if patients develop a varicella-like or shingles-like rash at any time after they received the vaccine, they will be requested to come back to the clinic within 72 hours of rash onset (preferably within 24 hours) for examination. subjects will be asked to provide a lesion swab/vesicular fluid in this case.


Eligibility criteria:
main inclusion criteria: 1. outpatient men or women aged 50 years or older 2. must have moderate-to-severe plaque psoriasis for at least 6 months, and for whom a decision to use biologic therapy has been made, with biologic therapy planned to be initiated within the next 4-6 weeks. 3. history of varicella, or having resided in canada for at least 30 years. main exclusion criteria: 1. have received varicella zoster vaccine vaccine or known allergies to the varicella zoster vaccine vaccine or its excipients including neomycin and gelatin 2. primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukemias, lymphoma, other conditions affecting the bone marrow or lymphatic system, immunosuppression due to hiv/aids, cellular immune deficiencies. 3. current use of non-topical antiviral therapy with known activity against varicella-zoster virus. 4. exposure to varicella or zoster within 28 days prior to vaccination. 5. patients who are diagnosed with herpes zoster at the time of the vaccination. 6. active untreated tuberculosis.

Keywords: live, attenuated virus varicella-zoster vaccine zostavax herpes zoster shingles
the effect of exergaming application and autogenic relaxation technique on psychological well-being and life engagement of nursing home residents: a randomi̇zed controlled tri̇al

Conditions: Psychological Well-being; Nursing Homes Residents; Aging; Exergaming; Mind-Body Therapies; Quality of Life; Health Promotion

Summary: this interventional clinical trial was conducted to evaluate the effects of antroyun (exergaming) and autogenic relaxation techniques on psychological well-being and life engagement among older adults living in nursing homes. participants were randomly assigned to one of three groups: antroyun intervention group, autogenic relaxation group, and a control group. interventions were applied twice per week for eight weeks. the results indicated that both interventions had a significant effect on improving psychological well-being and life engagement. the antroyun group showed faster and more marked improvements in earlier follow-ups, while the autogenic relaxation group demonstrated sustained benefits in later follow-ups. the control group did not show any significant changes over time. additionally, in the antroyun group, the number of game wins was positively correlated with improvements in psychological well-being and life engagement scores. this study was carried out as part of a doctoral dissertation at sivas cumhuriyet university.

this study was registered retrospectively due to its nature as a doctoral dissertation and institutional administrative timelines. although participant enrollment and data collection had already started, the study protocol and outcome measures were pre-specified and ethically approved prior to implementation. no interim analysis was conducted prior to registration. this registration is intended to enhance research transparency and integrity.

Eligibility criteria:
inclusion criteria: * age 65 years or older * residing in a nursing home * able to communicate and follow instructions * scoring 24 or above on the standardized mini mental test (smmt) * voluntary participation and written informed consent obtained exclusion criteria: * diagnosed with advanced cognitive impairment (smmt score \< 24) * diagnosed with severe psychiatric disorders (e.g., schizophrenia, severe depression) * having physical disabilities that prevent participation in the interventions (e.g., immobility, severe visual or auditory loss) * refusal or inability to provide informed consent

Keywords: exergaming autogenic relaxation psychological well-being life engagement nursing home residents
targeted memory reactivation during rem sleep in patients with social anxiety disorder

Conditions: Social Anxiety Disorder; Sleep

Summary: with this study, the investigators aim to use sleep and dreaming in order to enhance exposure therapy for social anxiety disorder (sad), by pairing the positive feedback phase of exposure (public talk) to an auditory stimulus during wake (associated sound) and subsequently applying this stimulus during sleep (targeted memory reactivation, tmr). exposure therapy sessions will take place in a virtual reality (vr) environment, while physiological measures during the preparation phase of public talk such as heart rate variability (hrv), skin conductance response (scr) and subjective level of anxiety (suds) will be used in order to assess treatment efficiency across the sessions. patients with sad according to dsm-5 criteria will be included. the main hypothesis of this study is that participants who are presented with the associated sound during sleep (tmr group) will have reduced intensity of social anxiety compared to participants with no such association (control group), after both a full night's sleep with auditory stimulation during rem sleep in the laboratory, and after 1 week of stimulation during rem sleep at home. in addition, it is expected that fear-related dreams may correlate with anxiety levels during wakefulness after 1 week of stimulation at home.


Eligibility criteria:
inclusion criteria: * patients with social anxiety disorder (according to dsm-5 criteria and liebowitz social anxiety scale \> 65) * aged between 16 and 40 yo * no current treatment for sad (cognitive-behavioral therapy, medications) exclusion criteria: * mood disorder, psychosis,other anxiety disorder or other mental disorders according to dsm-5 criteria * sleep disorder (e.g.,insomnia disorder, obstructive sleep apnea syndrome, restless legs syndrome) according to dsm-5 criteria * use of psychiatric medication * current treatment for sad (cognitive-behavioral therapy, medications) * neurological disease
effect of apple cider vinegar and metformin combination vs metformin alone in type 2 diabetics

Conditions: Diabetes Mellitus, Type 2

Summary: 'this study aims to compare the effect of metformin alone vs metformin plus apple cider vinegar in newly diagnosed type 2 diabetic patients

diabetes mellitus is one of the oldest diseases known to men and has been treated with multiple agents,organic and with the current pharmacological advancement,with multiple synthetic drugs as well. metformin has been considered first line for the treatment of type 2 diabetes, however presents itself with a side effect profile of gi distress, vitamin b12 deficiency,to name a few. vinegar has been used as therapeutic agent for centuries for multiple ailments including diabetes. this study aims to evaluate the combined effects of drug and natural therapy and compare it with conventional therapy.

Eligibility criteria:
inclusion criteria: * recently diagnosed type 2 diabetic patients taking metformin 750 mg daily as the oral antidiabetic agent * patients with hemoglobin a1c in the range of 6.5 to 7.5% exclusion criteria: * all newly diagnosed diabetic patients requiring a dosage other than 750 mg per day * patients on insulin therapy or any drugs for diabetes other than metformin * pregnant and lactating women * patients with food allergies to either apple or any source of vinegar * patients unable to communicate efficiently\\mentally challenged * type 2 diabetic patients with any of the complications of long standing uncontrolled diabetes
a comparative pharmacokinetic and pharmacodynamic study of sildenafil in adult smokers and non smokers

Conditions: Erectile Dysfunction; Smoking; Pharmacokinetics; Pharmacodynamics

Summary: smokers are at higher risk of developing erectile dysfunction (ed) independent of age and comorbidities. sildenafil is a cytochrome p3a4 (cyp3a4) substrate used for enhancing the erectile function in males. the study purpose is to determine the effect of smoking on male sexual function based on the international index of erectile function score (iief) and investigate the effect of smoking (cigarettes or marijuana) on the pharmacokinetics and pharmacodynamics of sildenafil.

the study is a randomized, single dose, one way, open label, parallel study in thirty-six (36) subjects randomized into three groups;group(1) included twelve(12) healthy non-smoker males, group(2) included twelve(12) healthy smokers (cigarettes) and group(3) included twelve(12) healthy smokers (marijuana). each group received a single dose of viagra 50 mg film coated tablet (sildenafil 50 mg) blood samples were collected at the following sampling intervals: pre-dose administration, 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8,10, 12 and 24 hours post dose. blood samples were centrifuged and plasma was separated and stored at -80 degree celsius till time of analysis. plasma concentrations of sildenafil were determined by liquid chromatography tandem mass spectrometry (lc/ms/ms)

Eligibility criteria:
inclusion criteria: * healthy male subjects * age 18-55 years. * ideal weight with ideal body mass index(bmi). * non-contributory history and normal physiological examination. * laboratory data within normal limits. * performance and compliance. * the subjects should be without known history of alcohol or drug abuse problems * subjects who are cigarette smokers * subjects who are cannabis smokers * subjects who are non-smokers exclusion criteria: * a known hypersensitivity to the drug. * gastrointestinal diseases. * auto immune diseases. * renal diseases or dysfunction. * cardiovascular disease of any type. * pancreatic disease including diabetes. * hepatic disease. * hematological, osteopathic, or pulmonary disease. * history of alcoholism or drug abuse. * serious psychological illness. * positive hiv. * abnormal (out of range) laboratory values. * subject who have taken any medication less than two weeks of the trials starting date. * subject who have donated blood or who have been in multiple dosing studies requiring a large volume of blood (more than 500 ml) to be drawn within six weeks preceding the start of the trials.
effect of nano-bio fusion gel on palatal wound healing after free gingival graft harvest.

Conditions: Free Gingival Graft

Summary: the main aim of soft tissue grafts is to treat mucogingival defects such as exposed root surfaces or augment gingival tissue dimensions. in single or multiple root coverage procedures, autogenous grafts are considered to be the gold standard. where the palate is considered to be the most frequent site for graft harvesting, this procedure is accompanied with complications such as postoperative pain and bleeding. despite all materials used in the literature, no proven golden standard exits. this study will compare the effect of nano-bio fusion gingival gel versus natural healing with stent as a palatal dressing in the management of wound healing and pain.

in the literature, there are many modalities proposed in an attempt to decrease such complications such as the use of prf, non-eugenol dressing coe-pack, medicinal plant extract, hyaluronic acid. despite all, no proven gold standard exits. nano- bio fusion gel is a highly functional paste containing (nano vitamin c, nano vitamin e and propolis extract) that was used before as an adjunct to scaling and root planning in the management of chronic periodontitis. owing to its natural composition, vitamin c enhances the synthesis, maturation, secretion and degradation of collagen. also, propolis extract is mainly composed of flavonoids possessing antimicrobial, anti-inflammatory and now recognized as owning regenerative capacities. whereas vitamin e acts as an antioxidant, free radical scavenger, facilitate angiogenesis and epithelialization. thus, nano bio fusion gel could be tested as a palatal wound dressing aiming to enhance postoperative wound healing and wound re-epithelization. palatal stent will be used in the control group which was previously used in several studies. the choice of the stent was to confirm that any observed effect will be due to the gel only as stent will be used in both groups. follow up will be over month.

Eligibility criteria:
inclusion criteria: * systemically healthy/controlled patients scheduled for various periodontal or peri-implant plastic surgeries, requiring palatal free gingival graft harvesting, either epithelialized or de-epithelialized. * compliant patients * good oral hygiene exclusion criteria: * uncontrolled systemic diseases * pregnancy or lactating females * patients with severe gagging reflex * patients unwilling to sign an informed consent

Keywords: nano-biofusion gel stent palatal wound
assessing the role of the nlrp3 inflammasome in intercritical gout

Conditions: Gout

Summary: gout is an autoinflammatory disease characterized by flares of painful joint inflammation. this inflammation occurs in response to uric acid that crystallizes. after a gout attack, patients usually enter a period that is accompanied by low grade inflammation but is otherwise relatively asymptomatic. gout is typically associated with certain markers, and this study is going describe specific markers in patients that are in between gout attacks. research has been focused on studying this phase between gout attacks in hopes to manage and prevent the onset of future gout attacks. biopsies will be taken from the affected joint and blood will be drawn from patients who are currently in between gout attacks. this work will provide important information regarding how crystals in the joint lining are associated with chronic inflammation in the periods between gout attacks. moreover, this study will identify novel biomarkers that may be useful in determining the severity of disease activity through a blood test.


Eligibility criteria:
inclusion criteria: 1. adult patients with gout diagnosed by a rheumatologist. 2. patients with a history of at least two gout attacks in the target joint 3. patients with a target joint amenable to biopsy. target joint defined as: joint that has been affected by acute gout attack at least twice in the 12 months prior to enrollment. ultrasound finds grade 2 gray-scale synovitis in joint. joint is amenable to biopsy. at the time of enrollment, the joint is without signs of acute inflammation: redness, swelling, and severe pain (\>7/10). exclusion criteria: 1. patients on anti-coagulation therapy. 2. patients with an active infection. 3. tophus present at the biopsy site. 4. target joint with signs of acute gout attack (pain \>7/10, redness, warmth) 5. known chondrocalcinosis
effect of single dose ketamine and magnesium on postoperative pain in patients undergoing bariatric surgery

Conditions: Obesity

Summary: opioid sparing analgesia is extremely important in the post-operative obese population. with more and more obese patients entering the operating room a multi-modal approach to analgesia is crucial. finding effective alternatives to opioid therapy is the rationale of this proposal. literature involving ketamine and magnesium in bariatric surgical patients is very sparse.

1. patient will be identified by surgeon and consented by member of the research team 2. patient will be randomized to one of three groups on the day of surgery 3. following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an iv infusion pump. 4. the subject will receive ketamine, ketamine plus magnesium or a placebo. 5. following surgery, the patient will be taken to the post anesthesia care unit (pacu) and set up with standard asa monitoring as well as end-tidal co2 via nasal cannula. a hydromorphone patient controlled analgesia (pca) pump will be set-up by nursing and given to the patient. standard dosing of 0.2 mg bolus, every 6 minutes with a maximum 2 mg will be the starting dose as is standard for these patients post-operatively. 6. primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively. .

Eligibility criteria:
inclusion criteria: 1. subjects undergoing laparoscopic sleeve gastrectomy 2. consenting adults age 18-80 3. asa ii to asa iii 4. ability to understand and use a pca 5. required to be hospitalized for at least 24 hours post-op exclusion criteria: 1. patient refusal 2. chronic opiate use (daily opiate use for \>3 months) 3. chronic kidney disease (creatinine\>2) 4. known allergy or adverse effect of ketamine, magnesium or hydromorphone 5. patients with documented psychiatry (maniac or mdp) history 6. patient unable to give informed consent 7. patient with limited or no english fluency

Keywords: opioid sparing ketamine obese magnesium
dna analysis in predicting response to antibody therapy in patients with follicular lymphoma treated on clinical trials calgb-50402 or calgb-50701

Conditions: Lymphoma

Summary: this research trial studies deoxyribonucleic acid (dna) analysis in predicting response to antibody therapy in patients with follicular lymphoma treated on clinical trials cancer and leukemia group b (calgb)-50402 or calgb-50701. studying samples of blood from patients with follicular lymphoma in the laboratory may help doctors predict how well patients will respond to treatment.

primary objectives: l. to test the hypothesis that killer immunoglobulin-like receptor (kir) and human leukocyte antigen (hla) genotypes predict overall response (partial response \[pr\], complete response\[cr\], and unconfirmed complete response \[cru\]) within 12 months to rituximab-containing monoclonal antibody combinations in follicular lymphoma patients treated on calgb protocols 50402 and 50701. secondary objectives: i. to test the hypothesis that kir and hla genotypes are associated with survival outcomes (progression-free survival \[pfs\] and overall survival \[os\]) in follicular lymphoma patients treated with rituximab-containing monoclonal antibody combinations on calgb protocols 50402 and 50701. outline: genomic dna is extracted from previously collected blood samples for kir and hla genotyping and polymorphism analysis.

Eligibility criteria:
inclusion criteria: * untreated follicular lymphoma * has received rituximab-containing monoclonal antibody therapy on calgb-50402 or calgb-50701 * patients have previously provided informed consent allowing correlative studies on genomic dna

Keywords: stage ii grade 1 contiguous follicular lymphoma stage ii grade 1 non-contiguous follicular lymphoma stage ii grade 2 contiguous follicular lymphoma stage ii grade 2 non-contiguous follicular lymphoma stage ii grade 3 contiguous follicular lymphoma stage ii grade 3 non-contiguous follicular lymphoma stage iii grade 1 follicular lymphoma stage iii grade 2 follicular lymphoma stage iii grade 3 follicular lymphoma stage iv grade 1 follicular lymphoma stage iv grade 2 follicular lymphoma stage iv grade 3 follicular lymphoma
long-term follow-up study of subjects with fabry disease who received lentiviral gene therapy in study avro-rd-01-201

Conditions: Fabry Disease

Summary: this is a multinational, long-term follow-up study to assess the long-term safety and durability of avr-rd-01 treatment in participants who received a single dose administration of lentiviral gene therapy in study avro-rd-01-201 (treatment study). no investigational product will be administered in this study. participants will continue periodic safety and efficacy assessments in this long-term follow-up study up to 15 years from avr-rd-01 gene therapy infusion.

participants enrolled in the avro-rd-01-201 study will be offered participation in the avro-rd-01-ltf01 study. the baseline visit for the avro-rd-01-ltf01 study will coincide with the participant's last visit in the avro-rd-01-201 study. participants confirmed eligible for the avro-rd-01-ltf01 study will be asked to return for study visits at approximately 6-month intervals for the first 4 years and annually thereafter for 10 years (for a total of 15 years from avr-rd-01 infusion) during which time continued safety, engraftment, and efficacy of treatment will be assessed.

Eligibility criteria:
inclusion criteria: 1. subject must have been enrolled and received avr-rd-01 in the avro-rd-01-201 study. exclusion criteria: 1. subject has any medical, psychological, or other condition that, in the opinion of the investigator: * might interfere with the subject's participation in the study (including consenting to procedures); and/or * poses any additional risk to the subject; and/or * might confound the results of any study-required assessments. 2. subject is currently enrolled in an avrobio-sponsored avr-rd-01 treatment study.

Keywords: fabry disease cell therapy gene therapy long-term follow-up lysosomal storage disorder lenti-viral
evaluation of the efficacy of novel ibuprofen acetaminophen combination formulations in the treatment of post-surgical dental pain

Conditions: Pain

Summary: this study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.


Eligibility criteria:
inclusion criteria: * males and females 16 to 40 years of age * moderate to severe post-operative pain following surgical extraction of three or more third molar teeth exclusion criteria: * presence of history of significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorder * pregnant or breastfeeding females

Keywords: ibuprofen acetaminophen pain molar extraction